NCT04321720

Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers

Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to explore whether different dosages of mustard flour in footbaths cause different effects on warmth development as well as on general well-being and the autonomic nervous system.

Detailed description

This is a blinded, four-arm randomized controlled trial with crossover design to explore the dose-response relationship of footbaths with different dosages of mustard flour in healthy volunteers, compared to a placebo control (footbath with warm water only). The main focus is on thermogenesis and warmth distribution, as assessed by high-resolution infrared thermography and questionnaire data before, during and after the intervention. In addition, effects on the autonomic nervous system are assessed by measuring various parameters of heart rate variability and pulse wave analysis.

Conditions

• Thermogenesis by Different-dosage Mustard Flour Footbaths

Interventions

Type	Name	Description
OTHER	3-g mustard footbath	A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.
OTHER	6-g mustard footbath	A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.
OTHER	12-g mustard footbath	A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.
OTHER	Warm water only	A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.

Timeline

• Start date: 2020-04-20
• Primary completion: 2020-08-25
• Completion: 2020-08-26
• First posted: 2020-03-25
• Last updated: 2020-09-21

Locations

1 site across 1 country: Germany